Jazz trumpets FDA approval of AML drug

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Dive Brief:

The Food and Drug Administration on Thursday approved a new treatment for certain types of acute myeloid leukemia, the second therapy for the aggressive blood cancer OK'd by the agency this month.

Developed by Irish pharma Jazz Pharmaceuticals plc, Vyxeos is a combination of two commonly used chemotherapies — daunorubicin and cytarabine — that when given in a single formulation helped patients live about three and a half months longer then when administered separately.

The drug is now approved for use in adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Jazz said it will launch the drug within a week.

Dive Insight:

Approval of Vyxeos (daunorubicin/cytarabine) follows close on the heels of Celgene's success with Idhifa (enasidenib), which the FDA cleared for use in relapsed/refractory AML patients with a certain mutation.

The two drugs add need treatment options for the blood cancer, which kills nearly 11,000 patients each year according to the National Cancer Institute. During 2017, more than 21,000 people will be diagnosed with AML.

Vyxeos is only approved for use in a small number of those patients. Therapy-related AML, which results from complications to chemotherapy or radiation, affects about 8% to 10% of all people treated for cancer — usually beginning five years after treatment.

Both t-AML and AML-MRC have low life expectancies. According to the FDA, this is the first approved treatment specifically for patients with certain types of high-risk AML.

Jazz Pharmaceutical gained access to Vyxeos through a May 2016 deal to acquire Celator Pharmaceuticals. Vyxeos could help diversify Jazz's revenue beyond its sleep drug Xyrem (sodium oxybate), which made up 73% of the company's product revenues in the first quarter of 2017.

The first generic version of Xylem, from Hikma Pharmaceuticals' subsidiary West-Ward Pharmaceuticals, was approved by the FDA in January 2017. But Jazz has delayed the threat by granting Hikma the right to sell an authorized generic from January 2023 (earlier under certain conditions).

Vyxeos had caught the eye of the Office of Prescription Drug Promotion (OPDP) at the Food and Drug Administration last fall, when Celator was warned about advertising Vyxeos without referring to the fact that it was still under investigation.